Identification and determination of phase II nabumetone metabolites by high-performance liquid chromatography with photodiode array and mass spectrometric detection

Nobilis, Milan; Holčapek, Michal; Kolářová, Lenka; Kopeckỳ, J.; Kunes, Martin; Svoboda, Zbyněk; Kvĕtina, J

doi:10.1016/j.chroma.2004.01.031

Cited by 27 publications

(29 citation statements)

References 9 publications

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“…Most of the earlier reports employ liquid-liquid extraction (LLE) using n-hexane-dichloromethane (Sheen and Her, 2004), diethyl ether (Nobilis et al, 2004) and ethyl acetate (Kobylinska et al, 2003), except for the work of Nobilis et al (2003), where they carried out sample preparation with SPE as well as LLE. The recoveries obtained with SPE in the present study were not quantitative but were consistent and reproducible.…”

Section: Methods Developmentmentioning

confidence: 99%

“…They identified nabumetone metabolites in biological samples (urine, bile and synovial fluids) and confirmed them by HPLC-MS and NMR spectroscopy. In another report (Nobilis et al, 2004), they identified and determined phase II nabumetone metabolites by HPLC with photodiode array and mass spectrometric detection. A method for simultaneous determination of nabumetone and testosterone in human plasma after derivatization with pentafluorophenyl hydrazine has been presented (Sheen and Her, 2004).…”

Section: Introductionmentioning

confidence: 98%

“…Nabumetone has been determined in pharmaceutical formulation by flow injection analysis with UV detection (Can et al, 2003). Mainly, methods based on HPLC with UV (Jager et al, 2000;Mikami et al, 2000;Qin et al, 1999;Nobilis et al, 2003), fluorescence (Ray and Day, 1984;Nobilis et al, 2003;Kobylinska et al, 2003) or photodiode array (Nobilis et al, 2004;Rao et al, 2005) detection have been proposed for nabumetone and/or its active metabolite. An extractionless determination of 6-MNA in human plasma was presented using HPLC, which had a lower limit of quantitation of 70 ng/mL at a signal-to-noise ratio of 8:1 (Jager et al, 2000).…”

Section: Introductionmentioning

confidence: 99%

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High‐throughput LC‐MS/MS assay for 6‐methoxy‐2‐naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study

Patel

Sharma²,

Sanyal

et al. 2008

Biomedical Chromatography

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A simple, precise and accurate assay for the determination of 6-methoxy-2-naphthylacetic acid (6-MNA), an active metabolite of nabumetone in human plasma, was developed and validated using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analyte (6-MNA) and propranolol (internal standard, IS) were extracted from 200 microL aliquot of human plasma via solid-phase extraction employing HLB Oasis cartridges and separated on a Discovery HS C18 (50 x 4.6 mm, 5 microm) column. Detection of analyte and IS was done by tandem mass spectrometry with a turbo ion spray interface operating in positive ion and multiple reaction monitoring acquisition mode. The total chromatographic runtime was 3.0 min with retention time for 6-MNA and IS at 1.97 and 1.26 min, respectively. The method was validated over a dynamic linear range of 0.20-60.00 microg/mL for 6-MNA with mean correlation coefficient r > or = 0.9986. The intra-batch and inter-batch precision (%CV) across five validation runs (lower limit of quantiation, low-, medium- and high-quality controls and upper limit of quantitation) was less than 7.5%. The accuracy determined at these levels was within -5.8 to +0.2% in terms of percentage bias. The method was successfully applied for a bioequivalence study of 750 mg nabumetone tablet formulation in 12 healthy Indian male subjects under fasted condition.

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Section: Methods Developmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

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High‐throughput LC‐MS/MS assay for 6‐methoxy‐2‐naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study

Patel

Sharma²,

Sanyal

et al. 2008

Biomedical Chromatography

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“…The same working group solved the determination of phase II metabolites. The structures of these phase II metabolites were solved by HPLC with MS detection [10]. Naproxen is generally used as internal standard.…”

Section: Introductionmentioning

confidence: 99%

Comparison of different stationary phases for bioanalytical studies of biologically active compounds

Zerzaňová¹,

Cisar

Klimeš

2006

J. Sep. Sci.

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In this study, the chromatographic behaviour of four mixtures of compounds was tested on columns possessing various surface properties. Cocaine, dimefluron, nabumetone, and tramadol were chosen as the test compounds. Cocaine is a tropane alkaloid, which is relatively often abused as a drug. This is why many papers have already been written about its determination in human biological samples. Dimefluron, a derivative of benzo[c]fluorene, is a new perspective drug being investigated for its potential antineoplastic effects. Nabumetone is a non-steroidal anti-inflammatory prodrug used for treatment of inflammatory and degenerative rheumatic diseases. Tramadol, derived from an opioid structure is used as an anodyne for treatment of severe pain. As a medicament it is usually determined either in biological samples or in pharmaceuticals. The above-mentioned model drugs were separated using chromatographic columns with C18, C8, palmitamidopropyl, and pentafluorophenylpropyl chains. The best conditions for separation of the individual compounds and their metabolites were chosen on the basis of resolution, retention times, and peak symmetry.

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“…4 Paracetamol (PAR), 4-hydroxyacetanilide is a widely-used analgesic and antipyretic drug. 5 T h e l i t e r a t u r e s u r vey r eve a l s t h a t s eve r a l chromatographic methods have been used for the analysis of NAB in biological fluids [6][7][8][9][10][11] and in pharmaceutical formulations. [10][11][12] Also colorimetric 13 and micellar stabilized room temperature phosphorescence quantitation 14 of NAB as single component, or in combinations with other drugs, has been reported.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous HPTLC determination of nabumetone and paracetamol in combined tablet dosage form

Gandhi¹,

Ranher²,

Deshpande³

et al. 2011

J. Braz. Chem. Soc.

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Um novo método de cromatografia em camada delgada de alta eficiência (HPTLC) para determinação simultânea de nebumetona e paracetamol em forma combinada em comprimido foi desenvolvido e validado. As separações foram efetuadas em placas de alumínio prerrecobertas com sílica gel 60 F 254 utilizando tolueno:propanol-2:ácido acético (8:2:0.1, v/v/v) como fase móvel. A determinação quantitativa das bandas foi feita por varredura densitométrica a 236 nm. Os fatores de retenção calculados para nebumetona e paracetamol foram 0,78 ± 0,03 e 0,32 ± 0,03, respectivamente. O método foi validado com relação à linearidade, exatidão, precisão e robustez. A curva de calibração mostrou-se linear dentro do intervalo de 50-250 ng por banda de ambas as drogas. O método tem sido aplicado com sucesso nas análises das drogas em formulações farmacêuticas. As porcentagens de precisão de ensaio (média ± desvio padrão) foram 99,89 ± 1,15 para nabumetona e 101,10 ± 0,71 para paracetamol, ambos de comprimidos disponíveis comercialmente.A new simple high performance thin layer chromatographic method (HPTLC) for simultaneous determination of nabumetone and paracetamol in combined tablet dosage form was developed and validated. The separations were carried out on Merck aluminum plates precoated with silica gel 60 F 254 , using toluene:2-propanol:acetic acid (8:2:0.1, v/v/v) as mobile phase. Quantitative determination of bands was done by densitometric scanning at 236 nm. The calculated retention factors for nabumetone and paracetamol were 0.78 ± 0.03 and 0.32 ± 0.03, respectively. The method was validated with respect to linearity, accuracy, precision and robustness. The calibration curves showed to be linear over a range of 50-250 ng per band for both drugs. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The percentages of assay (mean ± S.D.) were 99.89 ± 1.15 for nabumetone and 101.10 ± 0.71 for paracetamol, both of commercially available tablets.

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Identification and determination of phase II nabumetone metabolites by high-performance liquid chromatography with photodiode array and mass spectrometric detection

Cited by 27 publications

References 9 publications

High‐throughput LC‐MS/MS assay for 6‐methoxy‐2‐naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study

High‐throughput LC‐MS/MS assay for 6‐methoxy‐2‐naphthylacetic acid, an active metabolite of nabumetone in human plasma and its application to bioequivalence study

Comparison of different stationary phases for bioanalytical studies of biologically active compounds

Simultaneous HPTLC determination of nabumetone and paracetamol in combined tablet dosage form

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